Manufacturer's Devices - Hologic Inc.

Address:




10210 Genetic Center Drive



San Diego

CA 92121

United States


Authorised Representative/ UK Responsible Person
Name: Hologic Ltd.
Address:

Heron House 6 The Oaks Business Park Crewe Road Wythenshawe



Manchester

Lancashire M23 9HZ

England United Kingdom




Code/Term Type
General specimen collection kit IVD clinicalGeneral specimen collection kit IVD clinicalIVD General
Cytomegalovirus (CMV) nucleic acid IVD calibratorCytomegalovirus (CMV) nucleic acid IVD calibratorIVD Annex II List B
Cytomegalovirus (CMV) nucleic acid IVD controlCytomegalovirus (CMV) nucleic acid IVD controlIVD Annex II List B
Cytomegalovirus (CMV) nucleic acid IVD reagentCytomegalovirus (CMV) nucleic acid IVD reagentIVD Annex II List B
Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT)Cytomegalovirus (CMV) nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT)Human papillomavirus (HPV) high risk strain nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Mycoplasma genitalium nucleic acid IVD calibratorMycoplasma genitalium nucleic acid IVD calibratorIVD General
Mycoplasma genitalium nucleic acid IVD kit nucleic acid technique (NAT)Mycoplasma genitalium nucleic acid IVD kit nucleic acid technique (NAT)IVD General
SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)SARS-CoV-2 nucleic acid IVD kit nucleic acid technique (NAT)IVD General
SARS-CoV-2 nucleic acid IVD controlSARS-CoV-2 nucleic acid IVD controlIVD General
Urogenital specimen collection kit IVD clinicalUrogenital specimen collection kit IVD clinicalIVD General
SARS-CoV-2/influenza A/B nucleic acid IVD kit nucleic acid technique (NAT)SARS-CoV-2/influenza A/B nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple-type vaginitis-associated organism nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type vaginitis-associated organism nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple-type vaginitis-associated organism nucleic acid IVD calibratorMultiple-type vaginitis-associated organism nucleic acid IVD calibratorIVD General
Multiple-type vaginitis-associated organism nucleic acid IVD controlMultiple-type vaginitis-associated organism nucleic acid IVD controlIVD General
Zika virus nucleic acid IVD kit nucleic acid technique (NAT)Zika virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Zika virus nucleic acid IVD calibratorZika virus nucleic acid IVD calibratorIVD General
Multiple Mycobacterium species nucleic acid IVD kit nucleic acid technique (NAT)Multiple Mycobacterium species nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple Candida species nucleic acid IVD calibratorMultiple Candida species nucleic acid IVD calibratorIVD General
Multiple Candida species nucleic acid IVD controlMultiple Candida species nucleic acid IVD controlIVD General
Multiple Candida species nucleic acid IVD reagentMultiple Candida species nucleic acid IVD reagentIVD General
Neisseria gonorrhoeae nucleic acid IVD kit nucleic acid technique (NAT)Neisseria gonorrhoeae nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple Staphylococcus bacterial species culture isolate identification IVD kitMultiple Staphylococcus bacterial species culture isolate identification IVD kitIVD General
Beta-haemolytic Group B Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)Beta-haemolytic Group B Streptococcus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Beta-haemolytic Group B Streptococcus nucleic acid IVD controlBeta-haemolytic Group B Streptococcus nucleic acid IVD controlIVD General
Herpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD controlHerpes simplex virus 1 & 2 (HSV1 & 2) nucleic acid IVD controlIVD General
Sexually transmitted infection (STI) testing specimen collection kit IVD clinicalSexually transmitted infection (STI) testing specimen collection kit IVD clinicalIVD General
Laboratory container robotic transfer system IVDLaboratory container robotic transfer system IVDIVD General
Multiple respiratory disease-associated bacteria nucleic acid IVD kit nucleic acid technique (NAT)Multiple respiratory disease-associated bacteria nucleic acid IVD kit nucleic acid technique (NAT)IVD General
MRSA/MSSA nucleic acid IVD kit nucleic acid technique (NAT)MRSA/MSSA nucleic acid IVD kit nucleic acid technique (NAT)IVD General
MRSA/MSSA nucleic acid IVD controlMRSA/MSSA nucleic acid IVD controlIVD General
Fibronectin IVD kit enzyme immunohistochemistryFibronectin IVD kit enzyme immunohistochemistryIVD General
General specimen container IVD additive/mediumGeneral specimen container IVD additive/mediumIVD General
Chemiluminescent immunoassay analyser IVD semi-automatedChemiluminescent immunoassay analyser IVD semi-automatedIVD General
Urogenital specimen collection kit IVD clinicalUrogenital specimen collection kit IVD clinicalIVD General
Isothermal nucleic acid amplification analyser IVD laboratory automatedIsothermal nucleic acid amplification analyser IVD laboratory automatedIVD General
Buffered sample diluent IVD automated/semi-automated systemBuffered sample diluent IVD automated/semi-automated systemIVD General
Human papillomavirus (HPV) high-risk strain nucleic acid IVD calibratorHuman papillomavirus (HPV) high-risk strain nucleic acid IVD calibratorIVD General
Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Nucleic acid technique (NAT) chemiluminescent signal generation kit IVDNucleic acid technique (NAT) chemiluminescent signal generation kit IVDIVD General
Nucleic acid technique (NAT) chemiluminescent signal generation kit IVDNucleic acid technique (NAT) chemiluminescent signal generation kit IVDIVD General
Nucleic acid technique (NAT) kit IVDNucleic acid technique (NAT) kit IVDIVD General
Exogenous DNA/RNA internal control IVD kitExogenous DNA/RNA internal control IVD kitIVD General
Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)Multiple respiratory virus nucleic acid IVD kit nucleic acid technique (NAT)IVD General
Multiple respiratory virus nucleic acid IVD controlMultiple respiratory virus nucleic acid IVD controlIVD General
Hepatitis B virus nucleic acid IVD calibratorHepatitis B virus nucleic acid IVD calibratorIVD Annex II List A
Hepatitis B virus nucleic acid IVD controlHepatitis B virus nucleic acid IVD controlIVD Annex II List A
Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)Hepatitis B virus nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD reagentHIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD reagentIVD Annex II List A
Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)Multiple-type sexually transmitted pathogen nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List B
Hepatitis C virus nucleic acid IVD calibratorHepatitis C virus nucleic acid IVD calibratorIVD Annex II List A
Hepatitis C virus nucleic acid IVD controlHepatitis C virus nucleic acid IVD controlIVD Annex II List A
Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT)Hepatitis C virus nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A
HIV1 nucleic acid IVD calibratorHIV1 nucleic acid IVD calibratorIVD Annex II List A
HIV1 nucleic acid IVD controlHIV1 nucleic acid IVD controlIVD Annex II List A
HIV1 nucleic acid IVD kit nucleic acid technique (NAT)HIV1 nucleic acid IVD kit nucleic acid technique (NAT)IVD Annex II List A